ClearPoint System
K-Number: K222519 · 2022-09-16
ApplicantClearPoint Neuro, Inc.
Decision Date2022-09-16
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ClearPoint System is a medical device manufactured by ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-09-16 under approval number K222519. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearPoint System?
ClearPoint System is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by ClearPoint Neuro, Inc.. The 510(k) number is K222519.
When was ClearPoint System approved by the FDA?
ClearPoint System received FDA 510(k) clearance on 2022-09-16, under approval number K222519.
What company makes ClearPoint System?
ClearPoint System is manufactured by ClearPoint Neuro, Inc..
What is the FDA product code for ClearPoint System?
The FDA product code for ClearPoint System is HAW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.